AtriCure Recalls
13 recalls on record · March 13, 2013 to February 7, 2024 · Medical Devices
Recalls by year
13
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15
16
17
19
24
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
February 7, 2024Medical DevicesFDA
AtriCure, Inc. recalls Packaged, Tank Hose Assembly CMA-US, Product Catalog Number A001056
Hazard: AtriCure has identified certain lots of tank hose assemblies where a second-tier supplier provided incorrect tank hose assemblies. These tank hose assemblies were provided with an outer sheathing that does not have required pin perforations and the inner tube of the hose is not the correct material.
February 7, 2024Medical DevicesFDA
AtriCure, Inc. recalls Cryo Module Accessories Domestic CMA-OUS, Product Catalog Number A001053
Hazard: AtriCure has identified certain lots of tank hose assemblies where a second-tier supplier provided incorrect tank hose assemblies. These tank hose assemblies were provided with an outer sheathing that does not have required pin perforations and the inner tube of the hose is not the correct material.
July 3, 2019Medical DevicesFDA
AtriCure, Inc. recalls EPi-Sense Guided Coagulation System with Visitrax, MOdel No. CDK-1413 - Product Usage: The EPi-Sense Guided Coagulation
Hazard: The sterile package seal for the Epi-Sense Guided Coagulation System may be compromised, and has a worst-case reasonable harm of infection if used.
February 20, 2019Medical DevicesFDA
AtriCure, Inc. recalls COBRA FUSION 150 Ablation System (International Only), Catalog # (REF) 700-001MI
Hazard: There is a potential for patients undergoing ablation to experience an elevated risk for TE; during stand-alone off-pump procedures where cardio pulmonary bypass (CPB) was not utilized.
February 20, 2019Medical DevicesFDA
AtriCure, Inc. recalls COBRA FUSION 150 Ablation System, Catalog # (REF) 700-001S
Hazard: There is a potential for patients undergoing ablation to experience an elevated risk for TE; during stand-alone off-pump procedures where cardio pulmonary bypass (CPB) was not utilized.
February 20, 2019Medical DevicesFDA
AtriCure, Inc. recalls COBRA FUSION 150 Ablation System, Catalog # (REF) 700-001
Hazard: There is a potential for patients undergoing ablation to experience an elevated risk for TE; during stand-alone off-pump procedures where cardio pulmonary bypass (CPB) was not utilized.
February 20, 2019Medical DevicesFDA
AtriCure, Inc. recalls COBRA FUSION 50, Ablation System, Catalog # (REF) 700-002
Hazard: There is a potential for patients undergoing ablation to experience an elevated risk for TE; during stand-alone off-pump procedures where cardio pulmonary bypass (CPB) was not utilized.
February 15, 2017Medical DevicesFDA
AtriCure, Inc. recalls AtriClip" LAA Exclusion System with preloaded Gillinov-Cosgrove" Clip - A single PRO2 device is packaged in a convention
Hazard: A complaint of the PRO2 jaw breaking prior to surgery being performed.
November 30, 2016Medical DevicesFDA
AtriCure, Inc. recalls COBRA Fusion 50 Ablation System, COBRA Fusion 150 Ablation System, and COBRA Fusion Magnetic Retriever System. Model Nu
Hazard: Due to product design and process control, part of the device can separate and remain behind when the device is removed that can potentially cause permanent impairment or damage to body function or structure.
November 16, 2016Medical DevicesFDA
AtriCure, Inc. recalls AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip Product is used for the occlusion of the heart's le
Hazard: There is a potential for a component failure of the device which could necessitate medical intervention.
January 7, 2015Medical DevicesFDA
Atricure Inc recalls Cryogenic probe for cardiac ablation surgery, packaged individually in Tyvek pouches Product Usage: Cryogenic probe
Hazard: Affected product may have compromised sterility due to packaging defects. It was determined that some mishandling of the product during the packaging process could inadvertently damage the sterile barrier.
March 26, 2014Medical DevicesFDA
Atricure Inc recalls Reusable Clip Applier Manufactured by AtriCure, Inc., 6217 Centre Park Drive, West Chester, OH 45069. The Reusable Cl
Hazard: The firm was notified by a customer of a cracked spring in the handle of the RCD1 device.
March 13, 2013Medical DevicesFDA
Atricure Inc recalls Atricure Inc., Max1 Isolator Transpolar Pen. Model A000163. Used to ablate cardiac tissues during cardiac surgery usi
Hazard: Products from lot no. 41865 may have been sent out with Incorrect Instructions for Use (IFU) labeling.